Insight & Resources

De-Risking the Solid Form Landscape of an API

De-Risking the Solid Form Landscape of an API – how predictable stability and solubility can minimize development timelines and cost

The market for solid state services (including salt, polymorph and crystallization screening) is around $150M and there is a growing trend from pharmaceutical companies to outsource much of this activity to CDMOs such as Cambrex. Entrusting your project to an outsourced supplier requires careful consideration and de-risking the solid form landscape of an API early in development is of utmost importance to ensure its success as a viable drug candidate. For example, facile hydrate formation can drastically alter the processability, stability and aqueous solubility of a given API, and therefore controlling the solid state properties of the API can ultimately benefit the downstream processing and manufacturing. This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. It will present two Cambrex case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

This webinar will:

Provide an introduction and overview of the solid state market

Discuss the importance of de-risking the solid state landscape of an API

Consider examples of typical issues faced during development of an API

Provide a brief overview of hydrates, and why understanding their formation is so critical

Cambrex’s Edinburgh site is a world-leader in providing solid form development services for drug substance and drug product.